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CompletedNCT01109004Updated Dec 9, 2021Results posted

Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)

A Phase 3 interventional study of Lenalidomide and lenalidomide, bortezomib and dexamethasone in Multiple Myeloma, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 54 sites in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2021-12-09.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
758
Allocation
Randomized
Ages
Up to 70 Years
Sex
All
01

Study summary

The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.

Read the detailed description

The primary objective of the randomized trial is to compare three-year progression-free survival (PFS) between the three treatment arms as a pairwise comparison. Mobilization therapy will not be specified for the study. Randomization to three treatment arms will be done prior to the first transplants. All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive either a second autologous PBSC transplant with the same conditioning regimen as the first transplant or consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40 mg on Days 1, 8 and 15, and bortezomib 1.3mg/m\^2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles) or maintenance with lenalidomide (15 mg daily). All patients will also receive maintenance lenalidomide which will start after the second transplant, after the first autologous transplant or after consolidation therapy depending on the treatment arm. Maintenance therapy with lenalidomide will start at 10 mg daily for three months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

02

Conditions studied

  • Multiple Myeloma

Keywords

  • Symptomatic Multiple Myeloma
  • Lenalidomide
  • Anti-Myeloma Agents
  • Hematologic Disorders
  • Maintenance Therapy
  • Progression
  • Autologous Transplant
  • RVD Consolidation
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 758 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients meeting the criteria for symptomatic multiple myeloma (MM).
  • Patients who are 70 years of age, or younger, at time of enrollment.
  • Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
  • Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
  • Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
  • Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
  • Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
  • Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10\^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10\^6 CD34+ cells/kg patient weight.
  • Signed informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Patients who never fulfill the criteria for symptomatic MM.
  • Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
  • Patients with plasma cell leukemia.
  • Karnofsky performance score less than 70 percent.
  • Patients with greater than grade 2 sensory neuropathy (CTCAE).
  • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
  • Patients seropositive for the human immunodeficiency virus (HIV).
  • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
  • Patient has hypersensitivity to bortezomib, boron or mannitol.
  • Patient has received other investigational drugs with 14 days before enrollment.
  • Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
  • Female patients who are pregnant (positive B-HCG) or breastfeeding.
  • Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
  • Prior allograft or prior autograft.
  • Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
  • Patients unable or unwilling to provide informed consent.
  • Prior organ transplant requiring immunosuppressive therapy.
  • Patients with disease progression prior to enrollment.
  • Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation.
  • Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
  • Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
  • Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers.
  • Patients unable to unwilling to return to the transplant center for their assigned treatments.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
758 participants (actual)

Study arms

  • Active comparator
    Tandem auto transplant

    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

    Drug: Lenalidomide

  • Active comparator
    RVD consolidation

    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

    Drug: lenalidomide, bortezomib and dexamethasone

  • Active comparator
    Lenalidomide maintenance

    Initial autologous transplant followed by lenalidomide maintenance

    Drug: Lenalidomide

Interventions

  • DrugLenalidomide

    All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

    Also known as: Revlimid™

  • Druglenalidomide, bortezomib and dexamethasone

    All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

    Also known as: Revlimid™, Velcade®, and Decadron

  • DrugLenalidomide

    All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

    Also known as: Revlimid™

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Progression-free Survival (PFS)

    Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.

    Time frame: 38 months post-randomization

Secondary outcomes

  1. Percentage of Participants With Disease Progression

    Disease Progression is defined as progression of multiple myeloma, including one or more of the following: * A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL * 24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in the serum and urine * At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to any other cause To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk.

    Time frame: 38 months post-randomization

  2. Percentage of Participants With Overall Survival (OS)

    Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.

    Time frame: 38 months post-randomization

  3. Percentage of Participants With Treatment-related Mortality (TRM)

    TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.

    Time frame: Up to 38 months post-randomization

  4. Number of Participants With Treatment Response

    The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas

    Time frame: 1 and 2 years post-randomization

  5. FACT-G Total Score

    The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.

    Time frame: Up to 3 years post-randomization

  6. FACT-BMT Score

    The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.

    Time frame: Up to 3 years post-randomization

  7. FACT-BMT Trial Outcome Index

    The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.

    Time frame: Up to 3 years post-randomization

  8. MOS SF-36 Physical Component Summary

    The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

    Time frame: Up to 3 years post-randomization

  9. MOS SF-36 Mental Component Summary

    The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

    Time frame: Up to 3 years post-randomization

07

Results

Posted Jun 11, 2018

Participant flow

Participant flow — Overall Study
MilestoneTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Started247254257
Completed247254257
Not completed000

Outcome measures

PrimaryPercentage of Participants With Progression-free Survival (PFS)

Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.

Time frame:
38 months post-randomization
Reported as:
Number · percentage of participants
Percentage of Participants With Progression-free Survival (PFS)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Progression-free Survival (PFS)58.5 (51.7 to 64.6)57.8 (51.4 to 63.7)53.9 (47.4 to 60.0)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Log Rank · p = 0.87 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status (high risk vs. standard risk)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Log Rank · p = 0.37 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status (high risk vs. standard risk)
  • RVD Consolidation vs Lenalidomide Maintenance · Log Rank · p = 0.27 (The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.)The log rank test was stratified on risk status (high risk vs. standard risk)
SecondaryPercentage of Participants With Disease Progression

Disease Progression is defined as progression of multiple myeloma, including one or more of the following: * A reappearance of serum monoclonal paraprotein, with a level of at least 0.5 g/dL * 24-hour urine protein electrophoresis with at least 200 mg paraprotein/24 hours * Abnormal free light chain levels of \>10 mg/dl, only in patients without measurable paraprotein in the serum and urine * At least 10% plasma cells in a bone marrow aspirate or on trephine biopsy * Definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of new bone lesions or soft tissue plasmacytomas * Development of hypercalcemia (corrected serum Ca \>11.5 mg/dL or \>2.8 mmol/L) not attributable to any other cause To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating death prior to disease progression as a competing risk.

Time frame:
38 months post-randomization
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Progression
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Disease Progression39.8 (33.4 to 46.1)41.0 (34.7 to 47.0)45.6 (39.2 to 51.8)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Gray's test · p = 0.92 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Gray's test · p = 0.21 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
  • RVD Consolidation vs Lenalidomide Maintenance · Gray's test · p = 0.22 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
SecondaryPercentage of Participants With Overall Survival (OS)

Overall survival is defined as survival of death from any cause. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate overall survival at 38 months post-randomization.

Time frame:
38 months post-randomization
Reported as:
Number · percentage of participants
Percentage of Participants With Overall Survival (OS)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Overall Survival (OS)81.8 (76.2 to 86.2)85.4 (80.4 to 89.3)83.7 (78.4 to 87.8)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Log Rank · p = 0.26 (Two sided testing was performed at a significance level of 0.05)
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Log Rank · p = 0.53 (Two sided testing was performed at a significance level of 0.05)
  • RVD Consolidation vs Lenalidomide Maintenance · Log Rank · p = 0.57 (Two sided testing was performed at a significance level of 0.05)
SecondaryPercentage of Participants With Treatment-related Mortality (TRM)

TRM is defined as death prior to progression of multiple myeloma. To account for loss to follow-up of a few participants, the cumulative incidence of TRM at 38 months post-randomization was estimated using the Aalen-Johansen estimator, treating disease progression as a competing risk.

Time frame:
Up to 38 months post-randomization
Reported as:
Number · percentage of participants
Percentage of Participants With Treatment-related Mortality (TRM)
percentage of participantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Percentage of Participants With Treatment-related Mortality (TRM)1.7 (0.6 to 4.2)1.2 (0.3 to 3.3)0.5 (0.0 to 2.4)
Statistical analysis
  • Tandem Auto Transplant vs RVD Consolidation · Gray's test · p = 0.63 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
  • Tandem Auto Transplant vs Lenalidomide Maintenance · Gray's test · p = 0.15 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
  • RVD Consolidation vs Lenalidomide Maintenance · Gray's test · p = 0.33 (Two sided testing was performed at a significance level of 0.05)Death prior to disease progression was treated as a competing risk
SecondaryNumber of Participants With Treatment Response

The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas

Time frame:
1 and 2 years post-randomization
Reported as:
Count of participants · Participants
Number of Participants With Treatment Response
ParticipantsTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
1 Year — CR or sCR9712298
1 Year — VGPR or nCR565060
1 Year — Worse than VGPR393750
2 Years — CR or sCR9811793
2 Years — VGPR or nCR393741
2 Years — Worse than VGPR202126
SecondaryFACT-G Total Score

The Functional Assessment of Cancer Therapy-General (FACT-G) is a quality of life instrument that assesses the effects of cancer therapy on a patient's physical, social/family, emotional, and functional well-being. The assessment has 27 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-108, with higher scores indicating higher levels of overall well-being.

Time frame:
Up to 3 years post-randomization
Reported as:
Mean · score on a scale
FACT-G Total Score
score on a scaleTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Baseline79 ± 1.079 ± 1.077 ± 1.0
1 Year84 ± 1.384 ± 1.383 ± 1.2
2 Years84 ± 1.584 ± 1.385 ± 1.4
3 Years85 ± 1.684 ± 1.685 ± 1.7
SecondaryFACT-BMT Score

The Functional Assessment of Cancer Therapy-Bone Marrow Transplant scale (FACT-BMT) is a quality of life instrument that assesses the effects of bone marrow transplantation (BMT) on a patient's physical, social/family, emotional, and functional well-being while taking into consideration BMT-specific concerns. The assessment has 37 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-148, with higher scores indicating higher levels of overall well-being.

Time frame:
Up to 3 years post-randomization
Reported as:
Mean · score on a scale
FACT-BMT Score
score on a scaleTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Baseline107 ± 1.4107 ± 1.3105 ± 1.3
1 Year113 ± 1.7115 ± 1.7113 ± 1.6
2 Years114 ± 1.8115 ± 1.7115 ± 1.7
3 Years115 ± 2.0114 ± 2.1115 ± 2.2
SecondaryFACT-BMT Trial Outcome Index

The Functional Assessment of Cancer Therapy (FACT) Trial Outcome Index is a quality of life instrument that assesses the impact of bone marrow transplantation (BMT) on a patient's physical and functional well-being while taking into consideration BMT-specific concerns. The assessment has 24 questions, each scored on a Likert scale from 0-4. The overall score is computed by adding scores of the questions and falls in the range 0-96, with higher scores indicating higher levels of overall well-being.

Time frame:
Up to 3 years post-randomization
Reported as:
Mean · score on a scale
FACT-BMT Trial Outcome Index
score on a scaleTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Baseline64 ± 1.165 ± 1.063 ± 1.0
1 Year70 ± 1.272 ± 1.271 ± 1.1
2 Years73 ± 1.273 ± 1.373 ± 1.2
3 Years73 ± 1.471 ± 1.573 ± 1.5
SecondaryMOS SF-36 Physical Component Summary

The Medical Outcome Study (MOS) SF-36 Physical Component Summary is a subscale of the SF-36 intended to measure physical well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

Time frame:
Up to 3 years post-randomization
Reported as:
Mean · score on a scale
MOS SF-36 Physical Component Summary
score on a scaleTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Baseline37 ± 0.739 ± 0.738 ± 0.7
1 Year43 ± 0.843 ± 0.842 ± 0.7
2 Years44 ± 0.844 ± 0.943 ± 0.9
3 Years42 ± 1.042 ± 1.043 ± 1.0
SecondaryMOS SF-36 Mental Component Summary

The Medical Outcome Study (MOS) SF-36 Mental Component Summary is a subscale of the SF-36 intended to measure mental well-being. It is scored on a scale of 0-100, with higher scores indicating higher levels of well-being.

Time frame:
Up to 3 years post-randomization
Reported as:
Mean · score on a scale
MOS SF-36 Mental Component Summary
score on a scaleTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Baseline49 ± 0.748 ± 0.748 ± 0.8
1 Year50 ± 0.951 ± 0.850 ± 0.8
2 Years50 ± 1.050 ± 0.850 ± 1.0
3 Years51 ± 1.050 ± 1.151 ± 1.0

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tandem Auto Transplant—42/247 (17%)0/247 (0%)
RVD Consolidation—45/254 (17.7%)0/254 (0%)
Lenalidomide Maintenance—53/257 (20.6%)0/257 (0%)
Most frequent serious events
Showing 10 of 91
Most frequent serious events
EventTandem Auto TransplantRVD ConsolidationLenalidomide Maintenance
Pleural effusionRespiratory, thoracic and mediastinal disorders4/2471/2541/257
Small intestinal obstructionGastrointestinal disorders2/2471/2544/257
Pulmonary embolismRespiratory, thoracic and mediastinal disorders1/2470/2544/257
Acute myeloid leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/2473/2540/257
Myelodysplastic syndromeNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/2473/2540/257
SyncopeNervous system disorders1/2473/2540/257
CholecystitisHepatobiliary disorders1/2470/2543/257
Myocardial infarctionCardiac disorders2/2471/2541/257
Acute kidney injuryRenal and urinary disorders2/2470/2542/257
Deep vein thrombosisVascular disorders2/2471/2541/257

Baseline characteristics

Age, Continuous
Age, Continuous(years)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Median56 (28 to 70)57 (20 to 70)56 (30 to 70)56 (20 to 70)
Sex: Female, Male
Sex: Female, Male(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Female10010896304
Male147146161454
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Caucasian178192201571
African American503941130
Multiple/Other/Unknown19231557
Karnofsky Performance Score (KPS)
Karnofsky Performance Score (KPS)(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
90 or Greater182169172523
Less Than 90658585235
Disease Risk
Disease Risk(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Standard175178182535
High727675223
Initial Therapy
Initial Therapy(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Bortezomib/Lenalidomide/Dexamethasone141136143420
Bortezomib/Cyclophosphamide/Dexamethasone333540108
Lenalidomide/Dexamethasone24282274
Bortezomib/Dexamethasone29323293
Other19192058
Unknown1405
Time from Initial Therapy to Enrollment
Time from Initial Therapy to Enrollment(months)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
Median5 (2 to 14)5 (2 to 12)5 (2 to 12)5 (2 to 14)
Number of Lines of Therapy
Number of Lines of Therapy(Participants)Tandem Auto TransplantRVD ConsolidationLenalidomide MaintenanceTotal
1210213218641
2313637104
35128
Unknown1405

1 further baseline measures are reported on the registry.

08

Study locations

54 sites
  • Arizona Cancer Center
    Tucson, Arizona 85724, United States
  • City of Hope National Medical Center
    Duarte, California 91010-3000, United States
  • UCSD Medical Center
    La Jolla, California 92093, United States
  • University of California, San Francisco
    San Francisco, California 94143-0324, United States
  • Stanford Hospital and Clinics
    Stanford, California 94305, United States
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
  • Christiana Care Health System
    Newark, Delaware 19718, United States
  • University of Florida College of Medicine
    Gainesville, Florida 32610, United States
  • Florida Hospital Cancer Institute
    Orlando, Florida 32804, United States
  • H. Lee Moffitt Cancer Center
    Tampa, Florida 33624, United States
  • Blood and Marrow Transplant Program at Northside Hospital
    Atlanta, Georgia 30342, United States
  • Georgia Health Sciences University
    Augusta, Georgia 30912, United States
  • St. Lukes Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Illinois
    Chicago, Illinois 60612, United States
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
  • University of Kansas Hospital
    Kansas City, Kansas 66160, United States
  • Wichita CCOP
    Wichita, Kansas 67214, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Louisiana State University Health Sciences Center
    Shreveport, Louisiana 71130, United States
  • DFCI, Brigham and Womens Hospital
    Boston, Massachusetts 02114, United States
  • DFCI, Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Michigan Medical Center
    Ann Arbor, Michigan 48105-2967, United States
  • Karmanos Cancer Institute/BMT
    Detroit, Michigan 48201, United States
  • University of Minnesota
    Minneapolis, Minnesota 55455, United States
  • Washington University, Barnes Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-7680, United States
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
  • Roswell Park Cancer Center
    Buffalo, New York 14263, United States
  • North Shore University Hospital
    Lake Success, New York 11042, United States
  • Mount Sinai Medical Center
    New York, New York 10029, United States
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10174, United States
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
  • University of North Carolina Hospital at Chapel Hill
    Chapel Hill, North Carolina 27599-7305, United States
  • Duke University Medical Center
    Durham, North Carolina 27705, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Jewish Hospital BMT Program
    Cincinnati, Ohio 45236, United States
  • University Hospitals of Cleveland
    Cleveland, Ohio 44106-5061, United States
  • Ohio State/Arthur G. James Cancer Hospital
    Columbus, Ohio 43210, United States
  • University of Oklahoma Medical Center
    Oklahoma City, Oklahoma 73104, United States
  • Oregon Health & Science University
    Portland, Oregon 97239-3098, United States
  • Penn State College of Medicine, The Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
  • University of Pennsylvania Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • Thompson Cancer Survival Center
    Knoxville, Tennessee 37916, United States
  • Sarah Cannon Blood & Marrow Transplant Program
    Nashville, Tennessee 37203, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232-8210, United States
  • University of Texas Southwestern Medical Center
    Dallas, Texas 75390, United States
  • Baylor College of Medicine/The Methodist Hospital
    Houston, Texas 77030, United States
  • University of Texas, MD Anderson CRC
    Houston, Texas 77030, United States
  • Texas Transplant Institute
    San Antonio, Texas 78229, United States
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
  • West Virginia University Hospital
    Morgantown, West Virginia 26506, United States
  • University of Wisconsin Hospital & Clinics
    Madison, Wisconsin 53792-5156, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53211, United States
09

References and documents

Publications

  • Stadtmauer EA, Pasquini MC, Blackwell B, Hari P, Bashey A, Devine S, Efebera Y, Ganguly S, Gasparetto C, Geller N, Horowitz MM, Koreth J, Knust K, Landau H, Brunstein C, McCarthy P, Nelson C, Qazilbash MH, Shah N, Vesole DH, Vij R, Vogl DT, Giralt S, Somlo G, Krishnan A. Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial. J Clin Oncol. 2019 Mar 1;37(7):589-597. doi: 10.1200/JCO.18.00685. Epub 2019 Jan 17. PubMed 30653422 ↗

Individual participant data

Plan to share: Yes — Results will be published in a manuscript and supporting information submitted to NIH BioLINCC (including data dictionaries, case report forms, data submission documentation, documentation for outcomes dataset, etc where indicated).

Supporting information: Study protocol, Icf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01109004
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 22, 2010
Start date
May 2010
Primary completion
Jan 15, 2017
Completion
Mar 3, 2018
Results posted
Jun 11, 2018
Last update
Dec 9, 2021

Study contacts

Mary Horowitz, MD
study director · Center for International Blood and Marrow Transplant Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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National Heart, Lung, and Blood Institute (NHLBI)

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